EUGIA PHARMA FDA Approval ANDA 216244

ANDA 216244

EUGIA PHARMA

FDA Drug Application

Application #216244

Application Sponsors

ANDA 216244EUGIA PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION10MG/ML0ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDE
002INJECTABLE;INJECTION20MG/ML0ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

EUGIA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216244
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESMOLOL HYDROCHLORIDE","activeIngredients":"ESMOLOL HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESMOLOL HYDROCHLORIDE","activeIngredients":"ESMOLOL HYDROCHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-21
        )

)

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